Evaluation of Length of Stay After TF-TAVI (FAST-TAVI)

University Hospital, Rouen

Status: Completed

Conditions: Severe Symptomatic Aortic Stenosis

Treatments: Procedure: Transfemoral Transcatheter aortic valve implantation

Study type: Observational

Funder types: Other

Identifiers

NCT02956915

2016/012/HP

Details and patient eligibility

About

Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002. With increasing experience and improvements in valve design, the "minimalist" approach to transfemoral TAVI (using local anesthesia and fluoroscopic guidance) has become an attractive concept, and the technical feasibility of this approach has been well documented.

While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time period of 2007 to 2012. More contemporary data from other centers has been published showing that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains indeterminate with a lack of formal consensus.

Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly patients in addition to cost-saving benefits. Rouen University Hospital has previously published a retrospective study on the feasibility and safety of early discharge, in which discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our patients. Pre-existing pacemaker and the absence of acute kidney injury were independent predictors of a successful early discharge. Moreover, in a prospective study, Rouen University Hospital recently shown that early discharge afterelective TF-TAVI with SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no evident compromise in safety. Factors associated with failure of early discharge were postprocedural blood transfusion and permanent pacemaker implantation. But currently, there are no guidelines for the length of stay after a TF-TAVI.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable patients with severe symptomatic aortic stenosis
• Patient undergoing planned TF-TAVI with the SAPIEN-3 prosthesis,
• TF-TAVI using a minimalist approach of local anesthesia and conscious sedation

Exclusion criteria

• The use of other (than Edwards SAPIEN-3 or XT) transcatheter aortic valve devices.
• TF-TAVI requiring general anesthesia or surgical cut-down.
• TF-TAVI performed in unstable patients or on an urgent/emergent basis.
• Non-transfemoral routes of valve delivery (eg. transapical, transaortic, etc).
• Discharge back home impossible (including transfer in another hospital)
• Programmed transfer to another hospital

Trial design

300 participants in 1 patient group

patients with severe symptomatic aortic stenosis

Description:

Stable patients with severe symptomatic aortic stenosis undergoing planned Transfemoral Transcatheter aortic valve implantation with the SAPIEN-3 prosthesis will be included. TF-TAVI will be done using a minimalist approach of local anesthesia and conscious sedation.

Treatment:

Procedure: Transfemoral Transcatheter aortic valve implantation